J&J Ebola vaccine: "Every day counts"

Johnson & Johnson has accelerated its Phase 1, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies.

The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January.

"Because every day counts, we are substantially accelerating the production of our vaccine regimen," said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. "Through the unprecedented collaboration among the global health community, our goal is to bring this vaccine to families and frontline health care professionals as fast as possible."

Johnson & Johnson also announced today that Janssen, in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of 2 million regimens will be available through the course of 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period. This increased projection is an update to Janssen's previous goal of producing more than 1 million regimens by the end of 2015, with 250,000 regimens for broad application in clinical trials by May 2015.

"As a leader in the field of global health, we have a responsibility to act swiftly as Ebola continues to cause suffering among patients, families and health care workers in West Africa," said Alex Gorsky, Chairman and CEO of Johnson & Johnson.

Modelling by the London School of Hygiene and Tropical Medicine to advise the World Health Organization (WHO) indicates that to bring the epidemic under control, current projected demand for a preventive vaccine ranges from a minimum of 100,000 doses to protect frontline workers to a high-end of 12 million doses for large-scale adult vaccination in the three affected countries.

The Phase 1, first-in-human study will evaluate the safety and tolerability of a prime-boost vaccine regimen, in which patients are first given a dose to prime the immune system, and then a boost intended to enhance the immune response over time. The immune response generated by the regimen will also be evaluated longer term. Different regimens combining the vaccine components or placebo will be studied in 72 healthy adult volunteers. Additional clinical studies are planned to begin in the United States later this month and soon after in Africa. Further details of the study are posted on clinicaltrials.gov.

"We've been working at an unprecedented pace together with our partners to significantly accelerate our efforts," said Dr. Matthew Snape of the Oxford Vaccine Group and the study leader. "Initiating this study in the space of eight weeks represents a critical leap forward in being able to rapidly develop an Ebola prime-boost vaccine regimen, and these results will be vital to the design of future studies in broader populations."

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